The U.S. Food and Drug Administration says it is requiring safety-labeling changes to keep children and adolescents from being prescribed cough and cold medicines that contain codeine or hydrocodone.
The risks these medicines pose to children “outweigh their potential benefits” because these products contain opioid ingredients, the FDA says.
After safety-labeling changes are made, these products will no longer be indicated for use to treat cough in children, and will be labeled for use only in adults aged 18 years and older, the FDA said in its announcement Thursday.
Labeling for the medications also is being updated with additional safety information for adult use – including an expanded “Boxed Warning,” the FDA’s most prominent warning. The warning will mention the risks of misuse, abuse, addiction, overdose and death — and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children,” said FDA Commissioner Scott Gottlieb, M.D. “We know that any exposure to opioid drugs can lead to future addiction. It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.”
The new labeling will provide safety warnings that are consistent with the warnings on other opioid-containing drugs, including immediate-release opioid analgesics and extended-release and long-acting opioid analgesics.
This Genetic ‘Risk Score’ Can Better Predict Early Onset Heart Disease
A so-called “polygenic risk score,” which is based on multiple genetic differences, predicted significantly more cases of early-onset heart disease than standard tests for single genetic defects, according to new research published in the American Heart Association’s journal Circulation: Genomic and Precision Medicine .
Heart disease is the leading cause of death in the U.S., affecting primarily adults over the age of 60. In some cases, high blood levels of the “bad cholesterol,” LDL, result from a genetic defect called familial hypercholesterolemia (FH). Patients with this genetic defect are at increased risk for early-onset heart disease, defined in the study as before age 40 in men and age 45 in women. Many patients with early-onset heart disease do not have this single genetic defect, which can be measured by current tests.
The new study found that the newer polygenic risk score predicted a high risk for early-onset heart disease in 1 out of 53 individuals with FH. The prevalence of FH registered at 1 in 256 individuals as a result of the single genetic test for FH.
“Our results provide convincing evidence that the polygenic risk score could be added to the genetic investigation of patients with very early coronary artery disease,” said study lead author Sébastien Thériault, M.D., assistant professor at Laval University in Quebec, Canada, and researcher at the Quebec Heart and Lung Institute.
The investigators developed the polygenic risk score based on 182 genetic differences related to coronary artery disease, stated the American Heart Association in a news release. They then compared polygenic risk scores between study participants with and without early-onset heart disease.
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U.S. Infant Mortality Rate Highest Among Wealthy Nations, Report Says
The rate at which babies born in the United States die before reaching their first birthday — also known as the infant mortality rate — is higher compared to babies born in other wealthy countries, according to a new report published in the journal Health Affairs .
In the most recent decade studied (2001-2010), American babies were 76 percent more likely to die before they turn a year old than babies in the other 19 wealthy democracies within the Organization for Economic Co-operation and Development (OECD). Researchers found that 600,000 lives could have been saved since 1961 if the U.S. had kept pace with average childhood mortality rates in the other countries.
The main reasons the U.S. has fallen behind include higher poverty rates compared to other developed countries and a relatively weak “social safety net.”
Another factor in the high infant mortality rate is the increasing number of babies born prematurely. The U.S. prematurity birth rate is the highest in the developed world. The U.S. rate of “extreme” prematurity — babies born before 25 weeks — is three times higher than the OECD average.
The study included data on older children. The United Stands also stands out when it comes to deaths by injury. Americans teens, age 15 to 19, are 82 times more likely than teens in other rich countries to die from gunshot injuries, the report said.
“Policy interventions should focus on infants and on children ages 15–19, the two age groups with the greatest disparities, by addressing perinatal causes of death, automobile accidents, and assaults by firearm,” the researchers concluded.
Regular Exercise Can Improve Stiffening, Aging Heart After Age 65
Aging increases the risk of heart disease in part because of arterial stiffening, especially among individuals who have led sedentary lifestyles. But regular aerobic exercise can help reduce the risk of future heart-related issues for seniors well into retirement age, new research has found.
For exercise to be beneficial, it has to be frequent enough and initiated before age 65, according to the study by cardiologists at UT Southwestern and Texas Health Resources.
Before age 65, the heart can retain some plasticity and the ability to restrengthen, according to the findings. Each exercise session needs to be performed four to five times a week. Two to three times a week was not enough, the researchers found in an earlier study.
“Based on a series of studies performed by our team over the past five years, this ‘dose’ of exercise has become my prescription for life,” said senior author Dr. Benjamin Levine, director of the Institute and professor of internal medicine at UT Southwestern. “I think people should be able to do this as part of their personal hygiene – just like brushing your teeth and taking a shower.”
The study, published this week in the journal Circulation , found that incorporating aerobic exercise into a daily routine, about four to five times a week, has the potential of reversing or reducing the risk of heart failure in two years, effectively overcoming a lifetime of a sedentary living.